(57 days)
· M.U.S.T. Fenestrated Pedicle Screw
The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in conjunction with Meta+ Spine cement, the M.U.S.T. Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. M.U.S.T. Fenestrated Pedicle Screw System augmented with Meta+ Spine cement is intended for use at spinal levels where the structural integrity of the spine is not severely compromised.
· Meta+ Spine Cement
Meta+ Spine cement, when used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.
The purpose of this submission is to gain the clearance for the Meta+ Spine Cement to be used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, a Medacta M.U.S.T. Pedicle Screws System line extension including the following screws:
- A. Poly-Axial Screws with standard screw head design, Ø 5, 6 mm (Dual Diameter) and 7mm (Single Diameter)
- B. Poly-Axial Screws with large screw head design, Ø 7, 8, 9, 10 mm (Dual Diameter)
- C. Mono-Axial Screws, Ø 5, 6, 7 mm (Dual Diameter)
- D. Long Tab (LT) Poly-axial screws Ø 4.5. 5. 6. 7. 8 mm (Single Diameter).
The Meta+ Spine Cement as well as the M.U.S.T. Fenestrated Pedicle Screws are provided individually packed, sterile and single-use.
The provided text describes a 510(k) premarket notification for a medical device (Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System) and outlines the testing conducted to support its substantial equivalence to predicate devices.
However, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance data against predicate devices, rather than establishing specific, quantitative acceptance criteria and proving the device meets those criteria. The "Performance Data" section lists various non-clinical tests performed, but it does not specify quantitative acceptance criteria or report specific device performance results against those criteria in a table format.
Therefore, many of the requested details about acceptance criteria, test set specifics (sample size, provenance, expert adjudication, ground truth), and training set details for an AI/ML-based device cannot be extracted from this document. This submission is for a traditional medical device (bone cement and pedicle screws), not an AI/ML diagnostic or therapeutic device. As such, concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training" are not applicable to this type of submission.
Based on the information provided, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document as quantitative acceptance criteria with reported performance values in a table. The document states "testing activities were conducted to written protocols" and lists the types of tests. It asserts that "The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices with respect to the predicate devices." Implied acceptance is that the device performs equivalently to the predicate devices as per the listed tests.
Summary of Tests Performed (Implied Performance Goal: Substantial Equivalence to Predicate):
| Test Category | Specific Tests Mentioned | Reported Device Performance (as stated in document) |
|---|---|---|
| PERFORMANCE TESTING | Mechanical properties rationale according to ASTM F1717-21 | Supported substantial equivalence |
| M.U.S.T. Fenestrated screws pull-out test according to ASTM F543-17 | Supported substantial equivalence | |
| Geometrical analysis and comparison to prove fixation into the bone | Supported substantial equivalence | |
| Implant-implant & Implant-instrument interface rationale | Supported substantial equivalence | |
| Bone cement injection test on cadaver specimen and PU foam | Supported substantial equivalence (specifically, regarding different fenestration design and viscosity) | |
| PYROGENICITY | Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equiv. to USP ) | Supported substantial equivalence |
| Pyrogen test according to USP chapter | Supported substantial equivalence | |
| BIOCOMPATIBILITY | Assessment | Supported substantial equivalence |
| SHELF-LIFE | Evaluation | Supported substantial equivalence |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document refers to "cadaver specimen and PU foam" for the bone cement injection test, but no specific number of specimens/tests is given for any of the listed tests.
- Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective). This is unlikely to be relevant for non-clinical, in-vitro/ex-vivo biomechanical and material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. This document describes non-clinical performance testing of a physical medical device (bone cement and pedicle screws), not an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" for these tests would be derived from the physical properties and mechanical behavior measured against established ASTM standards and comparable predicate device data, not expert consensus on images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in studies involving human readers or AI output where subjective interpretation or consensus is needed (e.g., image reading). This is not relevant to the described biomechanical and material property tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not mentioned, nor would it be relevant for this type of device. This device is a physical implant and bone cement, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML algorithms. No such algorithm is part of this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. For the non-clinical tests performed, the "ground truth" is based on the physical and mechanical properties of the materials and devices as measured using validated test methods (e.g., ASTM standards) and compared against established performance benchmarks or predicate device specifications.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm requiring a training set for this device submission.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”